Formulation & Evaluation of Fast Dissolving Tablets of Amlodipine Besylate by Using Co-Processed Superdisintegrants
Jeevan T. Naikwade *
Department of Quality Assurance, SND College of Pharmacy, Babhulgoan Tal., Yeola Dist. Nasik 423401, Maharashtra, India.
Vikas V. Patil
Department of Pharmaceutical Chemistry, SND College of Pharmacy, Babhulgoan Tal., Yeola Dist. Nasik 423401, Maharashtra, India.
Mayur H. Katkade
Department of Quality Assurance, SND College of Pharmacy, Babhulgoan Tal., Yeola Dist. Nasik 423401, Maharashtra, India.
Vaibhav D. Thorat
Department of Quality Assurance, SND College of Pharmacy, Babhulgoan Tal., Yeola Dist. Nasik 423401, Maharashtra, India.
Tahir Ansari
Department of Quality Assurance, SND College of Pharmacy, Babhulgoan Tal., Yeola Dist. Nasik 423401, Maharashtra, India.
Chetan R. Vaidya
Department of Pharmaceutics, SND College of Pharmacy, Babhulgoan Tal., Yeola Dist. Nasik 423401, Maharashtra, India.
*Author to whom correspondence should be addressed.
Abstract
Aims: To formulate fast dissolving tablets of amlodipine besylate using co-processed superdisintigrant and evaluate the properties of fast dissolving tablets.
Study Design: Formulation, evaluation of fast dissolving tablets of amlodipine besylate.
Place and Duration of Study: Department of Quality Assurance S. N. D. College of Pharmacy Babhulgoan Yeola Dist Nashik 423401, between July 2012 to February 2013.
Methodology: In the present study, novel co-processed superdisintegrants were developed by solvent evaporation method using crospovidone and sodium starch glycolate in different ratios (1:1, 1:2 1:3 2:1, 3:1) in the fast dissolving tablet formulations. Drug and the developed excipients were characterized for compatibility studies with FTIR and DSC. The co-processed superdisintigrant mixture was evaluated for angle of repose, Carr’s index and Hausner’s ratio in comparison with physical mixture of superdisintegrants. Fast dissolving tablets of Amlodipine Besylate were prepared using co-processed superdisintegrants and evaluated for pre-compression and post-compression parameters. Effect of co-processed superdisintegrants (crospovidone and sodium starch glycolate) on wetting time, disintegrating time, drug content, in-vitro release, and stability parameters have been studied.
Results: The angle of repose of the developed excipients was found to be < 300 Compressibility (%) index in the range of 13.14 to 14.63 % and Hausner’s ratio in the range of 1.15-1.19. The prepared tablets were characterized by FTIR and DSC Studies there was no change in the result. Based on in-vitro dispersion time (approximately 40 sec), promising formulation CP5 was tested for in-vitro drug release pattern in phosphate buffer pH 6.8.
Conclusion: Among the designed formulations, the formulation (CP5) containing co-processed superdisintegrant (3:1 mixture of crospovidone and sodium starch glycolate) emerged as the overall best formulation based on drug release characteristics in phosphate buffer pH 6.8. From this study, it can be concluded that dissolution rate of amlodipine besylate could be enhanced by tablets containing co-processed superdisintegrant.
Keywords: Co-processed mixture, sodium starch glycolate, crospovidone, amlodipin besylate, FDT